Pilot Comparison of N-of-1 Trials of Light Therapy

Comparison of N-of-1 Trials of Light Therapy for Depressive Symptoms in Cancer Survivors

This study compares the effect of two N-of-1 trials on study compliance with an N-of-1 protocol and on satisfaction with participation in an N-of-1 trial. Using within-person analyses, the study also compares the effect of different types of light therapy on mood, fatigue, sleep, physical activity, and side effects within a mild to moderately depressed cancer survivor population. Ten participants will be randomized to the bright white versus dim red light therapy N-of-1 trial, while the remaining 5 participants will be randomized to a dim white versus dim red light comparator N-of-1 trial.

Study Overview

• Status: Completed
• Conditions: Depression; Cancer; Health Behavior
• Intervention / Treatment: Other: Litebook® Advantage; Other: Fitbit Flex2 TM

Detailed Description

Fatigue or low energy levels, trouble sleeping and feeling down are symptoms that represent some of the most important concerns in cancer survivors, across a range of cancer types. Despite the impact of these symptoms on quality of life, previous studies have shown that few cancer survivors are receiving adequate treatment for these symptoms.

Light therapy involves the use of a light box (a box that lights up) in close proximity for a specified amount of time each day. There can be big differences in the way light therapy affects individual patients. Patients can learn whether this therapy is helpful to them by engaging in an N-of-1 trial. An N-of-1 trial is an experiment conducted with one individual (N refers to "number of individuals in the trial"). In an N-of-1 trial of light therapy, a patient can try light therapy to learn whether it is beneficial to them. All participants will receive two light boxes. The boxes will be labeled "A" and "B." Each light box will emit a different intensity of light. An app will send reminder notifications to participants' smartphones each morning to remind them which light box they should be using, depending on the week. They will be asked to use Box A or Box B each morning for 30 minutes per day for 12 weeks

The purpose of this study is to empower cancer survivors with symptoms of fatigue, trouble sleeping or who are feeling down to learn whether light therapy is helpful for them.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• History of cancer (not including basal cell or squamous cell carcinoma, or carcinoma in situ)
• Current mild to moderate severity depressive symptoms (PHQ-8 score 5 to 19)
• iPhone user

Exclusion Criteria:

• Has not completed primary cancer treatment including initial chemotherapy, surgical resection, or radiation therapy
• Non-English speaking
• Severe depression (PHQ-8 score >=20) or active suicidal ideations
• Other severe mental illness that would preclude participation in a study that requires extensive self-monitoring, including depression with psychotic features, other psychotic disorder, bipolar disorder, severe personality disorder
• <6 months life expectancy due to cancer or other severe medical illness
• Other severe medical illness that would preclude ability to do daily self-tracking
• Unavailable for follow-up over the course of the 3 month trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bright white light vs dim red light; A balanced sequence (ABBA) over a 12 week period of bright white light and dim red light; alternating bright white and dim red light every 3 weeks. Subjects will receive 2 Litebook® Advantage lightboxes - 1 bright white and 1 dim red. Information such as mood, fatigue, sleep and light therapy side effects will be self-reported using a smartphone diary; physical activity and sleep will also be reported using a Fitbit Flex2 TM. Data visualization at 12 weeks.	Other: Litebook® Advantage; Standard system light therapy device used in an investigation to assess the feasibility of conducting a randomized trial design. The lightbox produces different wavelengths of the light identical to the peak wavelengths of the sun - bright white, dim white and red light.; Other Names: Litebook Advantage Portable Light Therapy; Other: Fitbit Flex2 TM; Standard system activity and sleep tracker; Other Names: Fitbit actigraph
ACTIVE_COMPARATOR: Dim white light vs dim red light; A balanced sequence (ABBA) over a 12 week period of dim white light and dim red light; alternating dim white and dim red light every 3 weeks. Subjects will receive 2 Litebook® Advantage lightboxes - 1 dim white and 1 dim red. Information such as mood, fatigue, sleep and light therapy side effects will be self-reported using a smartphone diary; physical activity and sleep will also be reported using a Fitbit Flex2 TM. Data visualization at 12 weeks.	Other: Litebook® Advantage; Standard system light therapy device used in an investigation to assess the feasibility of conducting a randomized trial design. The lightbox produces different wavelengths of the light identical to the peak wavelengths of the sun - bright white, dim white and red light.; Other Names: Litebook Advantage Portable Light Therapy; Other: Fitbit Flex2 TM; Standard system activity and sleep tracker; Other Names: Fitbit actigraph

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protocol Compliance	The proportion of participants randomized to the N-of-1 trial group who are compliant with the N-of-1 trial protocol	Length of study (3 months)
Participant Satisfaction	The proportion of participants randomized to the N-of-1 trial who are satisfied with the N-of-1 trial protocol	Length of study (3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms	At the single-patient level in the bright white light experimental arm, effect of bright light versus dim white light on mood as measured by a daily visual analog scale.	Length of study (3 months)
Fatigue	At the single-patient level in the bright white light experimental arm, effect of bright light versus dim white light on fatigue as measured by a daily visual analog scale.	Length of study (3 months)
Side effects	At the single-patient level in the bright white light experimental arm, effect of bright light versus dim white light on days with perceived side-effects as measured by a smart phone daily diary.	Length of study (3 months)
Physical activity	At the single-patient level in the bright white light experimental arm, effect of bright light versus dim white light on physical activity as measured by a Fitbit.	Length of study (3 months)
Treatment preference for bright white light therapy	Within the bright white light experimental arm, the proportion who preferred to continue bright white light after the conclusion of the N-of-1 trial.	Length of study (3 months)

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Ian Kronish, MD, MPH, Columbia University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 6, 2017
• Primary Completion (ACTUAL): December 31, 2018
• Study Completion (ACTUAL): December 31, 2018

Study Registration Dates

• First Submitted: May 24, 2017
• First Submitted That Met QC Criteria: May 25, 2017
• First Posted (ACTUAL): May 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 25, 2019
• Last Update Submitted That Met QC Criteria: June 24, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: N-of-1; Light Therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Imidacloprid
• Other Study ID Numbers: AAAR1273; HHSN261200800001E (Other Identifier: NIAID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No